Process Engineer II (Drug Product/Medical Device ...

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.A healthy heart is essential to good health. That''s why we''re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people''s health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeatsOur location in Sylmar, CA currently has an opportunity for a Process Engineer II (Drug Product/Medical Device Combination). We are seeking a Process Engineer II to support Cardiac Rhythm Management Product manufacturing process improvements required for new product approvals and sustaining product improvements.A successful candidate will have drug product and/or drug/device combination process development and manufacturing experience. The candidate will be expected to apply process engineering knowledge in support of technology transfer to clinical and commercial manufacturing at Abbott. This individual will provide dedicated process engineering support for human implantable products in clinical development through commercial production.WHAT YOU''LL DOProcess Engineering:Support commercial combination product manufacturing operations with technical evaluation of NCMR/CAPA, scale up, validation, and technology transfer. This includes drug product manufacturing (material preparation, mixing, molding, and inspection), reserve samples (creation, storage, and testing) and finished device assembly.Support of regulatory filings and inspections.Troubleshoot issues with product processing technologies and equipment. New Product Introduction:Provide process development expertise in specific areas such as formulation development, process characterization, sterile processing, tech transfer and process plies with U.S. Food and Drug Administration (FDA) regulations, other regulatory agencies, company policies, operating procedures, processes, and task assignments. Transfer of new device assembly requirements to manufacturing with hands-on technical support: including developing Six Sigma processes/documentation for routine clinical and/or commercial production.Ensure that qualification parameters and process validation are complete for drug product-Medical Device assembly requirements.Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Process Performance:Projects involve collaborating with cross-functional teams developing and executing tests, performing root cause analysis and participating in investigations. Also making presentations to internal/external customers, vendors, and senior managementConduct risk assessment for drug product operations non conformances, change controls, and implement appropriate CAPAs.Lead process modelling, data trending and advanced statistical & process analysis - present data/metrics to teams.Implement process improvement strategies to improve quality, reliability and/or reduce cost.Minimal domestic and international travel as needed.EDUCATION AND EXPERIENCE YOU''LL BRINGRequiredBachelor or Master degree in Chemical/Biochemical Engineering, Polymer Sciences/Engineering, Mechanical Engineering, Biomedical Engineering, or ScienceMinimum 3 year of process/equipment development and optimization experience in drug or medical devicesKnowledge of late stage or commercial products experience with strong focus on manufacturing support.Experience with Six Sigma, risk analysis methodologies, process characterization, process validation and process monitoring, scale-up, and/or technology transfer experience, PFMECA, DFMECA.Strong knowledge of Quality systems, drug product manufacturing and process validation. Work history with cGMPs, regulatory filings and compliance issues for drug product and combination devices.Excellent organizational, leadership, teamwork, written and verbal communication skills together with demonstrated ability to work in a highly matrix team environment with enthusiasm and a proactive positive attitude. PreferredMasters Degree (± 18 years) - Chemical/Biochemical Engineering, Polymer Sciences/Engineering, Mechanical Engineering, Biomedical Engineering, or ScienceWHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:A fast-paced work environment where your safety is our priorityProduction areas that are clean, well-lit and temperature-controlled Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

Created: 2021-11-29